Kornimate/medical-research-clean huggingface dataset:
hospital network study - preparation for a randomized evaluation of anti-pneumonia strategies

Conditions: Hospital-acquired Pneumonia; Ventilator Associated Pneumonia

Summary: hospital acquired and ventilator associated pneumonia (hap/vap) pose a significant burden to patients admitted to the intensive care unit (icu). reported incidence ranges from 10-16% in all icu patients (including hap and vap) and around 20-30% in ventilated patients (vap). patients with hap/vap have a high mortality rate. the estimated attributable mortality of vap is 6-13%. randomized controlled trials (rcts) are the gold standard for evaluating medical interventions, but are difficult to perform in this population. several preventive and therapeutic treatment options are being developed that will require evaluation in phase-iii trials. these trials are challenging due to the relatively low incidence of the outcome (e.g. hap/vap) or of the domain under study (e.g. specific antibiotic resistant infections) and the requirement of informed consent in critically ill patients. there is a need for a well-organized and well-trained international rct network that enables efficient execution of a series of rcts in this population. the aim of the current study is to set up an infrastructure to prospectively enroll patients at risk of hap/vap in icus in several european countries. site personnel will be trained to obtain a gcp (good clinical practice) certification (if not already done), to timely identify and enroll patients at risk of hap/vap, to timely identify occurrence of hap/vap, collect informed consent forms, collect source data, enter data into a clinical database, and use a dedicated system to reply to queries. site sample collection, processing, identifying the causative organism, and antibiotic susceptibility testing will be validated and adapted if required where possible. where site infrastructure and regulations allow, the possibility of automated data collection of included participants will be explored to ensure sustainability of the future platform. furthermore, collected data will be used to inform future diagnostic, preventive and therapeutic trials. e.g. they may support assumptions in sample size calculations and expected number of enrolled participants, they may help in prioritizing interventions, or they may be used in simulations of adaptive trials to optimize decision rules.


Eligibility criteria:
inclusion criteria: * age \>= 18 years * at risk of acquiring bacterial hap or vap during icu stay, defined as meeting all of the following criteria: * expected or documented hospital length of stay of more than 48 hours * admitted to the icu exclusion criteria: * death is deemed to be imminent or inevitable during this hospital admission and one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment
impact of genetic counseling for female first degree relatives of individuals with mental illness

Conditions: Schizophrenia; Bipolar Disorder; Schizoaffective Disorder

Summary: women with a close relative who has experienced mental illnesses like schizophrenia, bipolar disorder or schizoaffective disorder often have a poor understanding of the causes of the illness, and are often very worried about the chance that any children that they have will become affected with the same illness. often, because of this fear, these healthy women choose not to have children. genetic counseling is a process where information about the causes of illnesses, and about chances for family members of individuals with these illnesses to become similarly affected is provided in a supportive environment by a specially trained healthcare professional. this study will investigate whether genetic counseling can reduce perceptions of risk and stigma, and increase perceived control and knowledge about the causes of the illness, amongst women who have a first degree relative with a major mental illness.

we will recruit 75 women who have a close relative with a major psychiatric disorder (as defined above). each participant will be randomized into one of 3 groups of approximately equal size: one of which will receive genetic counseling within 1 month after enrollment (gc), another will receive the educational brochure within 1 month (eb), and the last will be assigned to waitlist (wt). after randomization (but prior to intervention for gc and eb groups, and within 1 month after enrollment for the wt group) we will gather baseline information regarding the 4 outcome measures (perceived risk and control, stigma, and knowledge). we will re-assess the 4 outcome measures immediately post-intervention for gc and eb groups. a further follow-up (for all groups) will be conducted two months after enrollment (which is 1 month post intervention for gc and eb groups).

Eligibility criteria:
inclusion criteria: * fluent in english, and * have a first degree relative diagnosed with schizophrenia, bipolar, or schizoaffective disorder, and * reside in bc, and be able to attend 3 study visits over 1.5 months

Keywords: schizophrenia bipolar disorder schizoaffective disorder genetic counseling risk perception stigma control knowledge family members sibling parent or child with schizophrenia sibling parent or child with bipolar disorder sibling parent or child with schizoaffective disorder
study to reduce symptoms of premature beats with ranolazine

Conditions: Premature Ventricular Beats

Summary: investigate whether ranolazine, a novel anti-anginal agent with antiarrhythmic properties, has a role in the management of symptomatic ventricular premature beats.

the main objective is to compare the effect of ranolazine versus placebo on premature ventricular beats (using 24-hour ambulatory electrocardiographic monitoring) for subjects with symptomatic palpitations. subject population will consist of seventy-two adult subjects of both sexes who have greater than 1,000 premature ventricular beats during initial monitoring.

Eligibility criteria:
inclusion criteria: * subjects male and female 18 years and older * symptoms of palpitations * greater than or equal to 1,000 ventricular premature beats during 24-hour electrocardiographic monitoring * completion of a consent form prior to pre-randomization holter monitor exclusion criteria: * moderate to severe symptomatic heart failure, new york heart association class iii/iv * moderate to severe symptomatic angina, canadian cardiovascular classification iii/iv * moderate to severe structural heart disease in the absence of an implantable cardiac defibrillator in a subject who would otherwise be eligible for a defibrillator (e.g. history of myocardial infarction and a left ventricular ejection fraction less than 30%) * clinically significant hepatic disease (cirrhosis or chronic hepatitis) or abnormal liver associated enzymes greater than three times the upper limits of normal * a baseline corrected qt interval greater than or equal to 500msec or history of congenital channelopathy (long qt syndrome, brugada syndrome) or torsades de pointes. * treatment with agents known to prolong the qtc interval * treatment with agents that are potent or moderately potent inhibitors of cyp3a, to include, but is not limited to the following: ketoconazole, hiv protease inhibitors (i.e. ritonavir), macrolide antibiotics (i.e. clarithromycin), diltiazem and verapamil * females who are pregnant, planning to get pregnant, or breast feeding ( females under the age of 55 years who have not previously undergone surgical sterilization procedures will have serum qualitative pregnancy testing) * thyroid stimulating hormone less than 0.27 iu/ml * serum magnesium less than 1.5mg/dl * serum potassium less than 3.5 meq/dl or greater than 5.0 meq/dl * estimated gfr less than 30 ml/min

Keywords: premature ventricular beats premature heart beats ranolazine
a suggested functional exercises program for patients with chronic mechanical low back pain

Conditions: Chronic Mechanical Low Back Pain

Summary: the aim of this study will be to investigate the effect of functional exercise on pain, functional disability and core strength in patients with chronic mechanical low back pain .

to our knowledge, there has been not enough studies that investigated the effect of core strengthening by functional exercise on pain, functional disability and core muscle strength in patients with chronic mechanical low back pain. therefore, this study may open up ways to other researchers to investigate and build up on this effect if present and address such an important issue. the finding of this proposed work may help patients with chronic mechanical low back pain by addressing their pain, functional limitation, and/or participation restrictions. consequently, this can speed up their recovery, return to work, decrease cost of treatment, improve psychological status, decrease level of irritability, and improve overall quality of life. patients with chronic mechanical low back pain will be recruited after approval of ethical committee of the faculty of physical therapy, cairo university. all participants will sign a written informed consent form. the subjects will be randomly assigned into one of two groups: * group i (control) will receive advices only. * group ii (experimental) will receive a suggested functional exercise program plus advises. the measurments will take before and after treatment programe .

Eligibility criteria:
inclusion criteria: * chronic mechanical low back pain and their age will be ranged from 20 -45 years. * history of chronic low back pain (≥3 months). * patients with body mass index (bmi) between 18-28 exclusion criteria: * age younger than 20 or older than 45 years of age. * history of any surgical procedure in the back or the lower extremities * back pain secondary to known specific pathology (e.g. infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder (e.g. ankylosing spondylitis) or cauda equine syndrome). * patient with lumbar instability including spondylolisthesis. * red flags (e.g. fever, unexplained weight loss, progressive weakness, radiation to lower limb, bowel and bladder dysfunction). * pregnancy.
relationship of patient-specific functional scale with shoulder functions: a prospective study

Conditions: Shoulder Impingement; Frozen Shoulder; Humeral Fractures; Rotator Cuff Tears; Disability Physical; Pain, Shoulder

Summary: the aim of the study is to examine the relationship between the patient- specific functional scale (psfs) and shoulder functions in the physiotherapy and rehabilitation program applied to patients with shoulder problems.


Eligibility criteria:
inclusion criteria: * having a shoulder pathology * being volunteer * having shoulder pain at least 3 months * being literate exclusion criteria: * having more than one upper extremity pathology * having an upper extremity pathology involving the neck and trunk * having a neurological finding
grape polyphenols and second-meal effect

Conditions: Obesity

Summary: the aim of this is study is to evaluate the effects of a single intake of grapes (a polyphenol-rich food) in postprandial metabolism in subjects with obesity, including a first intake (high-fat breakfast) after overnight fasting a second one (medium-fat lunch). studies on the effects of polyphenols on postprandial (glucidic and lipidic) metabolism have commonly been performed in animal models and have used grape extracts, ignoring the whole pool of polyphenols present in grapes (extractable and non-extractable polyphenols). besides, the contribution of polyphenols to the so-called second-meal effect has not been explored. it should be highlighted that this study aims to explore the potential beneficial role of fresh grapes, consumed as fruit; in order to ensure the stability of the product, they will be provided as freeze-dried milled material, but the amount received by the subjects could be incorporated into a common diet, being equivalent to 300 g of fresh grapes.

twenty-five subjects with obesity will be were recruited. detailed inclusion and exclusion criteria are provided below. the subjects will receive, after overnight fasting, either a monodose of freeze-dried grapes (equivalent to 300 g of fresh grapes) or isocaloric placebo solved in water, together with a high-fat breakfast. blood samples will be collected before the intake, up to 5 h after breakfast, then a medium-fat lunch will be provided and blood samples will be collected for three additional hours. both interventions will be separated by two weeks. the following determinations will be performed in blood samples collected at different periods: glucose, insulin, triglycerides, uric acid, viscosity, antioxidant capacity. additionally, a satiety test will be provided. it is expected that grape supplementation, as compared with an isocaloric placebo, causes significant modifications in all the parameters indicated. nevertheless, the primary outcome of this study is the area under the curve for glucose after the second meal (300-420 min from basal time).

Eligibility criteria:
inclusion criteria: * obesity (bmi = 30-40 kg/m2). exclusion criteria: * subjects with a pharmaceutical treatment set to modify blood pressure, lipid profile or glucose. * subjects with diagnoses of type 2 diabetes, cardiovascular diseases or thyroid diseases. * values above the following ones: glucose, \> 115 mg/dl; triglycerides, \> 350 mg/dl; total cholesterol, \> 280 mg/dl; systolic blood pressure, \> 150 mmhg; diastolic blood pressure, \> 100 mmhg * previous bariatric surgery. * volunteers participating in other studies (currently or during last year) or weight loss plans. * pregnant or breastfeeding women. * adherence to vegetarian diets or usual consumption of dietary supplements.

Keywords: polyphenols obesity grape postprandial insulin resistance second meal effect
the effects of glycemic optimization before gastric bypass surgery

Conditions: Type 2 Diabetes

Summary: metabolic surgery such as gastric bypass, gastric banding or sleeve gastrectomy operations can cause rapid and uncontrolled reductions in blood glucose. there is limited information on whether: * metabolic surgery is superior to modern medical care for glycaemic control and type 2 diabetes remission. * metabolic surgery is safe for microvascular complications of type 2 diabetes * good glycaemic control pre surgery has any effects on the long term glycaemia and complications of type 2 diabetes. this study aims to assess: 1. whether metabolic surgery is better for diabetes control compared to medical treatment. 2. whether metabolic surgery is safe for eye, nerve and kidney complications. 3. whether good sugar control before metabolic surgery improves the long term effects of sugar control and microvascular complications.

this is a prospective study involving 150 patients with type 2 diabetes mellitus (t2dm) and obesity. one hundred patients will undergo gastric bypass surgery whilst 50 will be treated with best medical care. the surgical patient group will be randomised to either immediate surgery or 3 months of medical glycaemic optimisation followed by surgery (n=50 group). intervention group a: patients will undergo gastric bypass surgery within 3 months after randomisation without any pre operative optimisation of glycaemic control. group b: patients will undergo gastric bypass 3-6 months after randomisation. during this period the group will receive modern best medical care based on the american diabetes association (ada)/european association for the study of diabetes (easd) guidelines. glycaemic optimisation will be achieved with particular attention to the avoidance of hypoglycaemia. group c: obese patients with t2dm (who choose not to have surgery) will be treated with best medical care based on the ada/easd guidelines including anti-diabetes/obesity pharmacotherapy, access to a trained dietician and exercise programme.

Eligibility criteria:
inclusion criteria: 1. adult patients with t2dm and bmi above 35kg/m2 2. hba1c ≥ 8.5% and/or the presence of at least one microvascular complication. exclusion criteria: * end stage retinopathy, nephropathy or neuropathy.

Keywords: diabetes bariatric surgery roux-en-y gastric bypass retinopathy neuropathy nephropathy
individual patient data analysis of viabahn for peripheral arterial disease

Conditions: Peripheral Vascular Diseases

Summary: to evaluate the effectiveness of the vsx device in pre-determined patient populations to understand the patient characteristics that impact outcomes.

rationale: studies on the efficacy of self-expanding covered stents for the treatment of patients with superficial femoral artery (sfa) occlusive disease have mainly focused on stent patency. subgroup analysis was often not feasible, related to small sample sizes. this pooled analysis of individual patient-level data provides larger sample sizes and a more heterogeneous population, which allows for the ability to perform subgroup analyses to identify patients that will most benefit from vsx treatment. the current analysis will provide insights into the effectiveness of the vsx device for specific subgroups. objective: to evaluate the effectiveness of the vsx device in pre-determined patient populations to understand the patient characteristics that impact outcomes. study design: multicenter retrospective individual patient data meta-analysis. study population: patients treated with a vsx device for de novo or restenotic lesions of the superficial femoral artery and previously enrolled in a prospective vsx study whom were treated for sfa disease with the latest generation heparin-bonded viabahn, and published in peer reviewed journals. main study parameters/endpoints: the primary study parameter is primary patency at 12-months. in addition, for all subjects and for subgroups as described further below, the following secondary endpoints will be evaluated through follow-up: primary patency at 24 months, primary assisted patency, secondary patency, freedom from target lesion revascularization (tlr) at 12 and 24 months, clinical improvement, minor and major amputation, mortality. the following subgroup analysis will be performed if sufficient data are available: critical limb threatening ischemia patients (rutherford 4-6), patients with intermittent claudication (rutherford 1-3), chronic total occlusions, by gender, by number of runoff vessels, lesion length, tasc ii lesion classification, calcified lesions, by device diameter.

Eligibility criteria:
inclusion criteria: 1. patient was enrolled and treated with the gore® viabahn® endoprosthesis with heparin bioactive surface device in a gore-sponsored or physician-sponsored study for de novo or restenotic lesions of the femoropopliteal artery. 2. lesions ≥10 cm in length and tasc c or d classification will be included 3. patient-level data can be obtained and pooled with other studies exclusion criteria: 1. patient was not formally enrolled in their corresponding study (e.g., training cases) 2. patient was enrolled for treatment of in-stent restenotic lesions. 3. patient has incomplete or missing data that does not allow for analysis. 4. case reports (n\<10 patients)

Keywords: peripheral artarial disease endovascular treatment endoprosthesis viabahn individual patient data analysis
vitamin d3 for the treatment of low vitamin d in cystic fibrosis

Conditions: Cystic Fibrosis; Vitamin D Deficiency

Summary: vitamin d deficiency is common in cystic fibrosis. vitamin d deficiency frequently persists despite aggressive treatment with ergocalciferol, a vitamin d preparation also known as vitamin d2. cholecalciferol, a vitamin d preparation also known as vitamin d3,may work better to increase vitamin d levels. vitamin d is important for absorption of calcium from the diet and bone health. vitamin d more recently has been found to play a role in regulating the normal inflammatory process. since cystic fibrosis is a state of excessive inflammation, vitamin d may be playing a role in cystic fibrosis. we hypothesize: cholecalciferol will work better to increase vitamin d levels in patients iwth cystic fibrosis and that it will have an effect on markers of inflammation.

vitamin d deficiency is common in cystic fibrosis (cf) and persists despite relatively high doses of ergocalciferol, vitamin d2. replacement has traditionally been focused upon maintenance of calcium and phosphorus homeostasis and bone health. however, non-classic roles of vitamin d have become increasingly recognized and the contribution of vitamin d deficiency to non-bone disorders has become apparent. vitamin d deficiency has been associated with increased risk of a variety of cancers, autoimmune diseases such as type 1 diabetes and multiple sclerosis, type 2 diabetes, tuberculosis, and myopathy. the connection between vitamin d and these disease states likely reflects vitamin d's role as a transcriptional regulator: it participates in cell cycle regulation and in the innate immune system mediates cathelicidin production following activation of toll-like receptors.one hallmark of cf is pulmonary hyper-inflammation with recurrent infections. additionally, malnutrition and decreased lean muscle mass threaten pulmonary function in cf. while vitamin d and its relation to bone has been explored in cf, the role of vitamin d in inflammation, lean body mass and strength, and pulmonary muscle strength has not been investigated. moreover, vitamin d replacement has traditionally been with ergocalciferol, vitamin d2. vitamin d3, cholecalciferol, has a longer half-life and is considered more potent. thus, cholecalciferol treatment of children and young adults with cf and vitamin d deficiency may be useful for attaining normal vitamin d status and for exploring the impact of vitamin d upon lean body mass, pulmonary muscle strength, and inflammation.

Eligibility criteria:
inclusion criteria: 1. subjects age 10-25 years 2. cystic fibrosis 3. 25-(oh)-d \< 20 ng/ml 4. fev1 \> 40% - exclusion criteria: 1. inability to perform pulmonary function or hand-grip tests 2. liver disease (including cirrhosis and portal hypertension) or baseline liver enzymes 21/2-fold greater than the upper limit of normal 3. acute use of glucocorticoids at time of testing 4. acute pulmonary exacerbation at time of testing 5. known non-adherence to enzyme replacement 6. hypercalcemia 7. engages in "suntanning

Keywords: cystic fibrosis vitamin d inflammation